Normal Healthy EyesNCT05134896
Visual Performance With Spatial Light Modulator
A study testing Spatial light modulator in people with Normal Healthy Eyes, run by University of Houston.
Trial summary
Eye's aberrations have been known to degrade human visual performance and the visual performance is significantly improved when correcting the aberrations in the central visual field. However, how the aberration correction affects the peripheral visual performance is not well understood. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Healthy Eyes
- What is being tested?
- Spatial light modulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Nov 2021to Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- A person is eligible for inclusion in the study if he/she:
- Is between the ages of 18 and 60.
- Has normal corneas i.e. no corneal infections, no systemic pink eye, no clinically significant dry eye, and no corneal dystrophies.
- Has refractive errors less than +/- 10.0 Diopters in both eyes.
Who cannot join
- A person will be excluded from the study if he/she:
- Adults between the ages of 18-60 who are unable to give informed consent
- Individuals below 18 years old
- Individuals above the age of 60
- Pregnant women (self-reporting, hormonal changes may alter the refractive status of the eye)
- Prisoners
Show all 12Show fewer
- Students for whom you have direct access to/influence on grades
- People who do not understand or speak English
- Has clinically significant dry eye.
- Has clinically significant cataract.
- Has spherical refractive error that exceeds the limits outlined above.
- Is unable to hold his or her head steady for the duration of study measurements.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Visual Performance After Optically Correcting the Eye's Aberration With a Spatial Light Modulator
Eye's aberrations have been known to degrade human visual performance and the visual performance is significantly improved when correcting the aberrations in the central visual field. However, how the aberration correction affects the peripheral visual performance is not well understood. Moreover, how central and peripheral vision interacts remains unclear.
To conduct the study, we will use an adaptive optics vision simulator equipped with a Shack-Hartmann wavefront sensor and a spatial light modulator (see details in procedures section of the protocol). This system is capable of noninvasively controlling the eye's optical quality and evaluating visual performance simultaneously over a wide area of visual space. This study provides insights into the visual performance in the periphery visual field, and interaction between central and peripheral visual fields.
The goal of this study is to evaluate the visual performance at central and peripheral visual fields after correcting the ocular aberrations. An optical system equipped with a liquid crystal spatial light modulator will be used to achieve this goal non-invasively.
- Conditions
- Normal Healthy Eyes
- Being tested
- Spatial light modulator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spatial light modulatorDevice
This device compensates for the eye's optical imperfections (aberrations) at the foveal and peripheral retina.
| Study group | Role | What they receive |
|---|---|---|
| normal healthy group | Experimental | Spatial light modulator Receives: Device: Spatial light modulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Snellen "Tumbling E" method will be used to determine the smallest letter that a subject can see.
Measured: up to 6 separate sessions (each session taking up to 2 hours)
Contrast sensitivity
Light and dark sinusoidal stripes (Gabor gratings) will used to determine the smallest contrast that a subject can see
Measured: up to 6 separate sessions (each session taking up to 2 hours)
Contrast perception
Light and dark sinusoidal stripes (Gabor gratings) will used to determine differences in contrast perceived by the central and peripheral visual system
Measured: up to 6 separate sessions (each session taking up to 2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study startNov 2021 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Healthy EyesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geunyoung Yoon, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05134896
- Sponsor's protocol ID
- STUDY00003209
- Status last verified
- Nov 2021
- First submitted
- 11 Nov 2021
- Last updated
- 26 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Performance After Optically Correcting the Eye's Aberration With a Spatial Light Modulator
- ClinicalTrials.gov ID
- NCT05134896
- Acronym / sponsor ID
- STUDY00003209
- Conditions
- Normal Healthy Eyes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 26 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Eye's aberrations have been known to degrade human visual performance and the visual performance is significantly improved when correcting the aberrations in the central visual field. However, how the aberration correction affects the peripheral visual performance is not well understood. Moreover, how central and peripheral vision interacts remains unclear.
To conduct the study, we will use an adaptive optics vision simulator equipped with a Shack-Hartmann wavefront sensor and a spatial light modulator (see details in procedures section of the protocol). This system is capable of noninvasively controlling the eye's optical quality and evaluating visual performance simultaneously over a wide area of visual space. This study provides insights into the visual performance in the periphery visual field, and interaction between central and peripheral visual fields.
The goal of this study is to evaluate the visual performance at central and peripheral visual fields after correcting the ocular aberrations. An optical system equipped with a liquid crystal spatial light modulator will be used to achieve this goal non-invasively.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| normal healthy group | Experimental | Device: Spatial light modulatorSpatial light modulator |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Is between the ages of 18 and 60.
- Has normal corneas i.e. no corneal infections, no systemic pink eye, no clinically significant dry eye, and no corneal dystrophies.
- Has refractive errors less than +/- 10.0 Diopters in both eyes.
Key exclusion criteria (12 listed)
- Adults between the ages of 18-60 who are unable to give informed consent
- Individuals below 18 years old
- Individuals above the age of 60
- Pregnant women (self-reporting, hormonal changes may alter the refractive status of the eye)
- Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spatial light modulatorThis device compensates for the eye's optical imperfections (aberrations) at the foveal and peripheral retina. | Device | normal healthy group |
Primary outcome
Visual acuity
Time frame: up to 6 separate sessions (each session taking up to 2 hours)
Snellen "Tumbling E" method will be used to determine the smallest letter that a subject can see.
Contrast sensitivity
Time frame: up to 6 separate sessions (each session taking up to 2 hours)
Light and dark sinusoidal stripes (Gabor gratings) will used to determine the smallest contrast that a subject can see
Contrast perception
Time frame: up to 6 separate sessions (each session taking up to 2 hours)
Light and dark sinusoidal stripes (Gabor gratings) will used to determine differences in contrast perceived by the central and peripheral visual system
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2021.
- Individual participant dataSharing planned: No
Related trials for Normal Healthy Eyes
RecruitingObservational study
Characterization of Diseases With Salivary Gland Involvement
Healthy Volunteer, Sjogren's Syndrome
Active, not recruitingObservational study
Analysis of Specimens From Individuals With Pulmonary Fibrosis
Pulmonary Fibrosis, Healthy Volunteers
RecruitingPhase 1
A Phase 1, First-in-Human Study of CND319 in Healthy Participants and Patients With Rheumatic Diseases
Healthy Participants Study, Rheumatoid Arthritis
Recruiting
Sociocultural & Biobehavioral Influences on Pain Expression and Assessment
Normal Physiology, Healthy Volunteers
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Disease to Test How HBM7020 is Tolerated and Absorbed in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Spatial light modulator in people with Normal Healthy Eyes, run by University of Houston.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Geunyoung Yoon, PhD (7137437860, gyoon2@central.uh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (time frame: up to 6 separate sessions (each session taking up to 2 hours)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2021.